INGELHEIM, Germany. - Thursday, July 17th 2014 [ME NewsWire]
(BUSINESS WIRE) For non-U.S. Media Only
Boehringer
Ingelheim today announced that for the first time the U.S. Food &
Drug Administration (FDA) has granted Breakthrough Therapy designation
for a treatment in idiopathic pulmonary fibrosis (IPF), a devastating
and fatal lung disease. Nintedanib* is an investigational therapy
currently under FDA and European Medicines Agency (EMA) review for IPF.
“We’re
excited nintedanib* has been granted Breakthrough Therapy designation
in the US, which we hope will make the treatment available to IPF
patients as quickly as possible. Currently there are no FDA-approved
treatments available for IPF. We are committed to working with all
regulatory bodies to make nintedanib* available to people living with
this serious and life-threatening lung disease,” said Professor Klaus
Dugi, Chief Medical Officer, Boehringer Ingelheim.
The Breakthrough
Therapy designation process was established by the FDA in 2012. It is
intended to facilitate and expedite the development and review of
treatments for serious or life-threatening conditions if preliminary
clinical evidence indicates that the therapy may demonstrate substantial
improvement over existing therapies on one or more clinically
significant endpoints.1
IPF is a debilitating and fatal lung disease
that causes permanent scarring of the lungs, difficulty breathing and
decreases the amount of oxygen the lungs can supply to the major organs
of the body.2 IPF affects as many as 14-43 people per 100,000
worldwide.3
Results from two global Phase III studies (INPULSIS™-1
and INPULSIS™-2) evaluating the efficacy and safety of nintedanib* for
the treatment of IPF were presented at the American Thoracic Society
(ATS) International Conference and published in the New England Journal
of Medicine in May 2014.4
Nintedanib* is the first targeted treatment
for IPF that has consistently demonstrated to slow disease progression
in IPF by significantly reducing the annual decline in lung function by
approximately 50%.4
This effect on disease progression was further
supported in the pooled data set by a positive signal in reducing the
risk of acute exacerbations by 38% (p=0.08) and a significant risk
reduction in confirmed or suspected acute exacerbation by 68%
(p=0.005).4
*Nintedanib is an investigational compound. Its safety and efficacy have not yet been fully established.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/16_july_2014_ipf.html
1
U.S. Food and Drug Administration/Center for Drug Evaluation and
Research/Center for Biologics Evaluation and Research. (2014) Guidance
for Industry: Expedited Programs for Serious Conditions - Drugs and
Biologics. Silver Spring, MD.
2 Raghu G., et al. An Official
ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis:
Evidence-based Guidelines for Diagnosis and Management. American Journal
of Respiratory and Critical Care Medicine. 2011; 183: 788–824, 2011.
3 Raghu G., et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006; 174:810-816
4
Richeldi, L., et al. Efficacy and Safety of Nintedanib in Idiopathic
Pulmonary Fibrosis. New England Journal of Medicine. 2014, Vol. 370,
pp.2071-2082. Published online on May 18, 2014.
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra
Phone: +49 1511 502-1148
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
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